Short name: Ami 227, generic name: Ferumoxtran, (USPIO)
Ferumox
tran is a substance of the class of
ultrasmall superparamagnetic iron oxide used as a lymph node specific
contrast agent for
MRI.
See also
Combidex®,
Sinerem® and
Ultrasmall Superparamagnetic Iron Oxide.
Partner(s):
Cytogen Corporation, National Cancer Institute.
An approvable letter was received from the U.S.
Food and Drug Administration for Combidex in June 2000. Advanced Magnetics, Inc. has submitted a complete response to the approvable letter received from the U.S.
Food and Drug Administration, which was accepted by the FDA and assigned a user fee goal date of March 30, 2005.
In Europe, a Dossier (the European equivalent of a NDA) was submitted by Advanced Magnetics' European partner,
Guerbet SA, to the European Medicines Evaluations Agency in December 1999.
(
Sinerem® is the brand name for this
USPIO in Europe manufactured by Guerbet,
Combidex® by Advanced Magnetics for the U.S. market)
Advanced Magnetics, Inc. changed its name in July 2007 to
AMAG Pharmaceuticals Inc. 
•
] and 822 definitions [
]
Further Reading:
(.pdf)
Random Page
top
